The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.

In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.

The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.Continue Reading ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry

In September 2021, we posted about the European Commission’s implementation of its new pharmaceutical strategy (which was also discussed in more detail in our posts on the strategyproposed amendments to orphan and paediatric legislation and the industry response). Readers will be aware that the focus of the Strategy is on the availability, accessibility and affordability of medicinal products, based on the view that current incentive models do not provide an adequate solution for unmet medical needs or appropriately incentivise investment in innovation. As part of its work on the revision of the EU pharmaceutical legislation, the European Commission launched a public consultation to seek views on the current framework and on some of the proposals for changes in order to support the European Commission’s impact assessment for the revision of the legislation.

Following this consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published an article entitled “Back Innovation, Boost Access” with its response to the EU pharmaceutical strategy consultations and some of the concerns raised by the Commission. This expresses EFPIA’s position that innovation is only meaningful if patients have access to it, but highlights that access is not always in the control of the pharmaceutical companies. It also describes the current status of access to medicines in the EU Member States, some of the reasons for the delays to access and EFPIA’s proposals to improve patient access to innovative medicines.Continue Reading EFPIA’s Response to EU Pharmaceutical Strategy Consultations

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued this week new guidance on working with patient groups. The document has been prepared by the EFPIA Patient Think Tank, which is a forum comprised of representatives of patient organisations and the research-based pharmaceutical industry.

The new guide provides an additional point of reference and supplements the 2011 EFPIA Patient Organisation Code of Practice. It underlines the rationale for interactions between the pharmaceutical industry and patient organisations, providing clear principles that justify engagement between these two groups and a practical list of potential hurdles and proposed solutions. It is not applicable to interactions with individual patients but the rationale underpinning the guide may be applied to such interactions too.

Principles for Engagement

The guide recognises the benefits of effective collaboration between patient organisations and industry in ensuring that the patient perspective is taken into account when decisions which affect patients are made. However establishing an appropriate engagement between the industry and patients organisations without breaching the legal restrictions governing these interactions represents a challenge. The following 5 principles have been distilled by the Think Tank as necessary to ensure compliance:

  • Clarity of Purpose – a legitimate need for the interaction and the desired outcomes must be identified in advance.
  • Transparency – of aims and in particular of financial relationships between the two groups; any compensation paid to patient organisations and their representatives, should be proportional and commensurate with experience, expertise and time invested.
  • Independence – of decision-making, policies and communications helps to ensure credibility; funding from a wide range of sources is therefore always preferable. (NB: the EFPIA Patient Organisation Code prohibits its members from requiring to be sole funders of patient organisations or patient organisation’s activities.)
  • Mutual Respect – reflecting a collaborative approach, valuing the contribution of both parties.
  • Non-interference in the healthcare professional-patient relationship.

Continue Reading New European Guidelines on working with patient groups